Genzyme Pays $32.5 Million Criminal Fine For Seprafilm Marketing

Sanofi SA unit Genzyme Corp. agreed last month to a $32.5 million fine to resolve criminal charges that it encouraged surgeons to use its Seprafilm surgical product in unapproved ways that contaminated it, and suggested without enough proof that it was safe for certain cancer surgeries. Genzyme’s fine and admissions of wrongdoing are part of an at least two-year long deferred prosecution agreement with the U.S. Department of Justice (DOJ) over its charges in Florida federal court about the Massachusetts-based pharmaceutical company’s Seprafilm surgical device.

Genzyme’s conduct took place before French pharmaceutical giant Sanofi acquired it in 2011, according to the Justice Department. Seprafilm is a device used to minimize the formation of scar tissue after surgery that could cause organs to attach. Genzyme admitted that it urged surgeons to use the device in unapproved ways that led to it becoming contaminated, including converting the film into an injectable slurry, according to the DOJ.

The pharmaceutical company also admitted that it marketed the product to suggest that it was safe to use in gynecologic cancer surgeries, even though, according to the DOJ, that claim was based on a study that involved only 14 patients. The agency said this amounted to misbranding. U.S. Attorney A. Lee Bentley III of the Middle District of Florida said in a statement:

Patients rely heavily on the integrity and efficacy of claims made by manufacturers of medical products. When manufacturers make misleading statements about using their products in ways that have not been approved by the [U.S. Food and Drug Administration], patient care, confidence, and safety are put at risk.

The U.S. Food and Drug Administration (FDA) approved Seprafilm in 1996 for pelvic and abdominal surgeries, namely laparotomies, which are open surgeries that involve making a large incision to allow direct access to internal organs. The DOJ alleged that Genzyme encouraged surgeons to use the product in unapproved ways as laparotomies became increasingly replaced by the comparatively less invasive laparascopic surgeries, for which Seprafilm was not approved.

Genzyme said in the agreement that even though it forbade off-label marketing, its sales representatives were allowed to talk to surgeons about how Seprafilm could be converted into “slurries” that could be used in laparoscopic surgeries. The sales representatives apparently told the surgeons that such use would be off-label. Laparoscopic surgeries involve small incisions through which surgeons insert tubes and narrow instruments.

Surgeons began to inject Seprafilm slurries through these tubes, according to a statement of facts that accompanies the settlement agreement. The pharmaceutical company even allowed its sales representatives to be present for surgeries that used these Seprafilm slurries. The settlement agreement says in 2007 sales representatives were told only that they “should not comment on the use of the product in this fashion if you observe it.”

Genzyme apparently took a stricter approach in 2008, telling its representatives then that they were no longer allowed to discuss the use of slurries, but surgeons nevertheless continued to increasingly use them, according to the statement of facts. It wasn’t until February 2009 that Genzyme banned its representatives from attending surgeries that used these slurries, according to the statement of facts. As part of the settlement, the DOJ also required Genzyme to improve its compliance programs, according to the prosecutors’ statement.